Read all of this leaflet carefully before you start taking this medicine because it contains -important information for you.
-If Biktarvy has been prescribed for your child, please note that all the information in this leaflet -is addressed to your child (in this case please read “your child” instead of “you”).
Read all of this leaflet carefully before you start taking this medicine because it contains -important information for you.
-If Biktarvy has been prescribed for your child, please note that all the information in this leaflet -is addressed to your child (in this case please read “your child” instead of “you”).
What is in this leaflet
-Biktarvy contains three active substances:
-Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in -adults, adolescents and children 2 years of age and older, who weigh at least 14 kg.
-Biktarvy reduces the amount of HIV in your body. This will improve your immune system and reduce -the risk of developing illnesses linked to HIV infection.
Do not take Biktarvy
-If you are currently taking any of the following medicines:
-If any of these apply to you, do not take Biktarvy and tell your doctor immediately.
-Warnings and precautions
-Talk to your doctor before taking Biktarvy:
-If you have hepatitis B infection. Liver problems may become worse after you stop taking -Biktarvy.
-Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first. For more details, see -section 3, Do not stop taking Biktarvy.
-If you have had kidney disease or if tests have shown problems with your kidneys. Your -doctor may order blood tests to monitor how your kidneys work when starting and during -treatment with Biktarvy.
-While you are taking Biktarvy
-Once you start taking Biktarvy, look out for:
-If you notice any of these symptoms, tell your doctor immediately. For more information see -section 4, Possible side effects.
-There is a possibility that you may experience kidney problems when taking Biktarvy over a long -period of time (see Warnings and precautions).
-This medicine is not a cure for HIV infection. While taking Biktarvy you may still develop infections -or other illnesses associated with HIV infection.
-Children and adolescents
-Do not give this medicine to children under 2 years of age, or weighing less than 14 kg regardless -of age. The use of Biktarvy in children under 2 years of age, or weighing less than 14 kg has not yet -been studied. For children and adolescents who weigh 25 kg or more, Biktarvy 50 mg/200 mg/25 mg -film-coated tablets are available.
-Loss of bone mass has been reported in some children from 3 to less than 12 years of age who -received one of the medicinal products (tenofovir alafenamide) contained in Biktarvy. The effects on -long term bone health and future fracture risk in children is uncertain. Your doctor will monitor your -child’s bone health as needed.
-Other medicines and Biktarvy
-Tell your doctor or pharmacist if you are taking, have recently taken or might take any other -medicines. Biktarvy may interact with other medicines. As a result, the amounts of Biktarvy or other -medicines in your blood may change. This may stop your medicines from working properly, or may -make any side effects worse. In some cases, your doctor may need to adjust your dose or check your -blood levels.
-Medicines that must never be taken with Biktarvy:
-Talk to your doctor if you are taking:
-ulcer-healing medicines containing sucralfate
-Tell your doctor if you are taking any of these medicines. Do not stop your treatment without -contacting your doctor.
-Get advice from a doctor or pharmacist if you are taking:
-Antacids and magnesium supplements: you will need to take Biktarvy at least 2 hours before -antacids or supplements containing aluminium and/or magnesium. Or you can take Biktarvy with -food at least 2 hours after.
-Iron supplements: you will need to take Biktarvy at least 2 hours before iron supplements, or you -can take them together with food.
-Pregnancy and breast-feeding
-If you have taken Biktarvy during your pregnancy, your doctor may request regular blood tests and -other diagnostic tests to monitor the development of your child. In children whose mothers took -nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection -against HIV outweighed the risk of side effects.
-Do not breast-feed during treatment with Biktarvy. This is because some of the active substances -in this medicine pass into human breast milk. Breast-feeding is not recommended in women living -with HIV because HIV infection can be passed on to the baby in breast milk. If you are -breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as -possible.
-Driving and using machines
-Biktarvy can cause dizziness. If you feel dizzy when taking Biktarvy, do not drive or ride a bicycle -and do not use any tools or machines.
-Biktarvy contains sodium
-This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially -‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist -if you are not sure.
-There are two strengths of Biktarvy tablets. Your doctor will prescribe the appropriate tablet for your -age and weight.
-The recommended dose is:
-Children 2 years of age and older, who weigh at least 14 kg but less than 25 kg: one tablet each -day with or without food (one 30 mg/120 mg/15 mg tablet).
-Due to the bitter taste, it is recommended not to chew or crush the tablet. -If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the -tablet one after the other to get the full dose. Do not store the split tablet.
-The score line on the tablet is only there to help you break the tablet if your child has difficulty -swallowing it whole.
-The 90-day multipack contains three 30-day packs together.
-If you are on dialysis, take your daily dose of Biktarvy following completion of dialysis.
-If you take more Biktarvy than you should
-If you take more than the recommended dose of Biktarvy you may be at higher risk of side effects of -this medicine (see section 4, Possible side effects). -Contact your doctor or nearest emergency department immediately for advice. Keep or take the tablet -bottle or carton with you so that you can easily describe what you have taken.
-If you forget to take Biktarvy
-It is important not to miss a dose of Biktarvy.
-If you miss a dose:
-If you vomit less than 1 hour after taking Biktarvy, take another tablet. If you vomit more than 1 hour -after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.
-Do not stop taking Biktarvy
-Do not stop taking Biktarvy without talking to your doctor. Stopping Biktarvy can seriously affect -how future treatment works. If Biktarvy is stopped for any reason, speak to your doctor before you -restart taking Biktarvy tablets.
-When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist. This is -very important because the amount of virus may start to increase if the medicine is stopped for even a -short time. The disease may then become harder to treat.
-If you have both HIV infection and hepatitis B, it is especially important not to stop your Biktarvy -treatment without talking to your doctor first. You may require blood tests for several months after -stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is -not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
-Like all medicines, this medicine can cause side effects, although not everybody gets them.
-Possible side effects: tell a doctor immediately
-Common side effects -(may affect up to 1 in 10 people)
-Uncommon side effects
-(may affect up to 1 in 100 people)
-Rare side effects
-(may affect up to 1 in 1000 people)
-Other effects that may be seen during HIV treatment
-The frequency of the following side effects is not known (frequency cannot be estimated from the -available data).
-During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This -is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV -medicines themselves. Your doctor will test for these changes.
-Reporting of side effects -If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects -not listed in this leaflet. You can also report side effects directly via the national reporting system -listed in Appendix V. By reporting side effects you can help provide more information on the safety -of this medicine.
Keep this medicine out of the sight and reach of children.
-Do not use this medicine after the expiry date which is stated on the carton and bottle or blister strips -after {EXP}. The expiry date refers to the last day of that month.
-Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not -use if the seal over the bottle opening is broken or missing.
-Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to -throw away medicines you no longer use. These measures will help protect the environment.
What Biktarvy contains
-The active substances are bictegravir, emtricitabine and tenofovir alafenamide. Each Biktarvy tablet -contains bictegravir sodium equivalent to 30 mg of bictegravir, 120 mg of emtricitabine and tenofovir -alafenamide fumarate equivalent to 15 mg of tenofovir alafenamide.
-The other ingredients areTablet coreMicrocrystalline cellulose (E460), croscarmellose sodium (E468), magnesium stearate (E470b).
-Film-coatingPolyvinyl alcohol (E203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide red -(E172), iron oxide black (E172).
-What Biktarvy looks like and contents of the pack
-Biktarvy 30 mg/120 mg/15 mg film-coated tablets are pink, capsule-shaped, film-coated tablets, -debossed with “BVY” on one side and a score line on the other side of the tablet.
-The tablets are supplied in a bottle. Not all pack sizes may be marketed.
-Biktarvy comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets. -Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. -The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Leia com atenção todo este folheto antes de começar a tomar este medicamento, pois contém informação importante para si.
-Se Biktarvy foi prescrito para a criança a seu cargo, tenha em atenção que todas as informações neste folheto são dirigidas à criança a seu cargo (neste caso, leia “a criança a seu cargo” em vez de “você”).
O que contém este folheto:
-Biktarvy contém três substâncias ativas:
-Biktarvy é um comprimido único para o tratamento da infeção pelo vírus da imunodeficiência -humana 1 (VIH-1) em adultos, adolescentes e crianças com idade igual ou superior a 2 anos, que -pesem pelo menos 14 kg.
-Biktarvy diminui a quantidade de VIH no seu corpo. Isto irá melhorar o seu sistema imunológico e -diminuir o risco de desenvolvimento de doenças ligadas à infeção pelo VIH.
Não tome Biktarvy
-Se qualquer uma destas situações se aplicar a si, não tome Biktarvy e informe imediatamente o seu médico.
-Advertências e precauções
-Fale com o seu médico antes de tomar Biktarvy:
-Não pare de tomar Biktarvy se tiver hepatite B. Fale primeiro com o seu médico. Para obter mais informação, consulte a secção 3, Não pare de tomar Biktarvy.
-Enquanto estiver a tomar Biktarvy
-Assim que começar a tomar Biktarvy, fique atento a:
-Se observar quaisquer destes sintomas, informe o seu médico imediatamente. Para obter mais -informação, consulte a secção 4, Efeitos indesejáveis possíveis.
-Existe a possibilidade de vir a ter problemas nos rins se tomar Biktarvy durante um longo período de -tempo (ver Advertências e precauções).
-Este medicamento não é uma cura para a infeção pelo VIH. Enquanto tomar Biktarvy pode -desenvolver na mesma infeções ou outras doenças associadas com a infeção pelo VIH.
-Crianças e adolescentes
-Não dê este medicamento a crianças com menos de 2 anos de idade, ou que pesem menos de 14 kg -independentemente da idade. A utilização de Biktarvy em crianças com menos de 2 anos de idade ou -que pesem menos de 14 kg ainda não foi estudada. Para crianças e adolescentes que pesem 25 kg ou -mais, estão disponíveis comprimidos revestidos por película de Biktarvy 50 mg/200 mg/25 mg.
-Foi notificada perda de massa óssea em algumas crianças com idade entre 3 e menos de 12 anos que -receberam um dos medicamentos (tenofovir alafenamida) contido em Biktarvy. Os efeitos na saúde -óssea a longo prazo e o risco futuro de fratura em crianças é incerto. O seu médico monitorizará a -saúde óssea do seu filho conforme necessário.
-Outros medicamentos e Biktarvy
-Informe o seu médico ou farmacêutico se estiver a tomar, tiver tomado recentemente, ou se vier a tomar outros medicamentos. Biktarvy pode interferir com outros medicamentos. Como resultado, -as quantidades de Biktarvy ou dos outros medicamentos no seu sangue podem alterar-se. Isto pode -fazer com que os seus medicamentos parem de funcionar corretamente ou piorar quaisquer efeitos -indesejáveis. Em alguns casos, o seu médico pode precisar de ajustar a sua dose ou verificar os níveis -dos medicamentos no seu sangue.
-Medicamentos que nunca podem ser tomados com Biktarvy:
-Se estiver a tomar qualquer um destes medicamentos, não tome Biktarvy e informe o seu médico imediatamente.
-Fale com o seu médico se estiver a tomar:
-Informe o seu médico se estiver a tomar qualquer um destes medicamentos. Não pare o seu -tratamento sem contactar o seu médico.
-Consulte um médico ou farmacêutico se estiver a tomar:
-Consulte o seu médico ou farmacêutico antes de tomar Biktarvy se estiver a tomar algum destes medicamentos.
-Antiácidos e suplementos de magnésio: terá de tomar Biktarvy, pelo menos, 2 horas antes de -tomar antiácidos ou suplementos contendo alumínio e/ou magnésio. Ou pode tomar Biktarvy com -alimentos, pelo menos, 2 horas depois.
-Suplementos de ferro: terá de tomar Biktarvy, pelo menos, 2 horas antes de tomar suplementos de -ferro ou pode tomá-los juntamente com alimentos.
-Gravidez e amamentação
-Se está grávida ou a amamentar, se pensa estar grávida ou planeia engravidar, consulte o seu -médico ou farmacêutico antes de tomar este medicamento.
-Se tomou Biktarvy durante a gravidez, o seu médico pode pedir-lhe para efetuar análises ao sangue e -outros testes de diagnóstico regulares para verificar o desenvolvimento da sua criança. Nas crianças -cujas mães tomaram inibidores nucleósidos da transcriptase reversa (INTR) durante a gravidez, o -benefício da menor possibilidade de infeção pelo VIH é superior ao risco de sofrerem efeitos -indesejáveis. -Não amamente durante o tratamento com Biktarvy. Isto deve-se ao facto de algumas das -substâncias ativas deste medicamento serem excretadas no leite humano. A amamentação não é -recomendada em mulheres que vivem com VIH, uma vez que a infeção pelo VIH pode ser transmitida -ao bebé através do leite materno. Se estiver a amamentar ou planeia vir a amamentar, deve falar com -o seu médico o mais rapidamente possível.
-Condução de veículos e utilização de máquinas
-Biktarvy pode causar tonturas. Se sentir tonturas enquanto estiver a tomar Biktarvy, não conduza nem -ande de bicicleta e não utilize quaisquer ferramentas ou máquinas.
-Biktarvy contém sódio
-Este medicamento contém menos do que 1 mmol (23 mg) de sódio por comprimido, ou seja, é -praticamente “isento de sódio”.
Tome este medicamento exatamente como indicado pelo seu médico. Fale com o seu médico ou -farmacêutico se tiver dúvidas.
-Existem duas dosagens de comprimidos de Biktarvy. O seu médico irá prescrever o comprimido -apropriado para a sua idade e peso.
-A dose recomendada é:
-Crianças com idade igual ou superior a 2 anos, que pesem pelo menos 14 kg, mas menos de -25 kg: um comprimido por dia com ou sem alimentos (um comprimido de 30 mg/120 mg/15 mg).
-Devido ao sabor amargo, recomenda-se que não mastigue ou esmague o comprimido. -Se tiver dificuldade em engolir o comprimido inteiro pode dividi-lo ao meio. Tome ambas as metades -do comprimido uma a seguir à outra para obter a dose total. Não guarde o comprimido dividido.
-A ranhura no comprimido existe apenas para ajudá-lo a partir o comprimido se a criança a seu cargo -tiver dificuldade em engoli-lo inteiro. -A embalagem múltipla de 90 dias contém um conjunto de três embalagens de 30 dias.
-Consulte um médico ou farmacêutico se estiver a tomar:
-Consulte a secção 2 para obter mais informação sobre como tomar estes medicamentos com -Biktarvy.
-Se estiver a fazer diálise, tome a sua dose diária de Biktarvy após terminar a diálise.
-Se tomar mais Biktarvy do que deveria
-Se tomar mais do que a dose recomendada de Biktarvy pode ter um maior risco de efeitos indesejáveis -com este medicamento (ver secção 4, Efeitos indesejáveis possíveis).
-Entre imediatamente em contacto com o seu médico ou aconselhe-se junto do serviço de urgência -mais próximo. Mantenha ou leve o frasco ou embalagem de comprimidos consigo para que facilmente -possa descrever o que tomou.
-Caso se tenha esquecido de tomar Biktarvy
-É importante que não falhe nenhuma dose de Biktarvy.
-Caso se tenha esquecido de tomar uma dose:
-Se vomitar em menos de 1 hora após a toma de Biktarvy, tome outro comprimido. Se vomitar mais de -1 hora após a toma de Biktarvy, não necessita de tomar outro comprimido até ao seu próximo -comprimido de acordo com o esquema habitual.
-Não pare de tomar Biktarvy
-Não pare de tomar Biktarvy sem falar com o seu médico. A interrupção do tratamento com -Biktarvy pode afetar gravemente a sua resposta a um tratamento futuro. Se o tratamento com Biktarvy -for interrompido por qualquer razão, fale com o seu médico antes de voltar a tomar os comprimidos de -Biktarvy.
-Quando a quantidade de Biktarvy começar a escassear, obtenha mais junto do seu médico ou -farmacêutico. É muito importante que o faça porque a quantidade de vírus pode começar a aumentar se -o medicamento for interrompido, mesmo por um curto período de tempo. A doença pode então tornarse mais difícil de tratar.
-Se tiver infeção por VIH e hepatite B, é particularmente importante não parar o tratamento com -Biktarvy sem previamente consultar o seu médico. Pode necessitar de análises ao sangue durante -vários meses após interrupção do tratamento. Em alguns doentes com doença hepática (do fígado) -avançada ou cirrose, a interrupção do tratamento não é recomendada, uma vez que pode levar a um -agravamento da sua hepatite, que pode ser potencialmente fatal.
-Informe imediatamente o seu médico se surgirem quaisquer sintomas novos ou pouco habituais após parar o tratamento, particularmente sintomas que associaria à sua hepatite B.
-Caso ainda tenha dúvidas sobre a utilização deste medicamento, fale com o seu médico ou -farmacêutico.
Como todos os medicamentos, este medicamento pode causar efeitos indesejáveis, embora estes não se -manifestem em todas as pessoas.
-Efeitos indesejáveis possíveis: informe o seu médico imediatamente
-Se observar estes ou quaisquer outros sintomas de inflamação ou infeção, informe o seu médico imediatamente.
-Efeitos indesejáveis frequentes -(podem afetar até 1 em cada 10 pessoas)*
-Efeitos indesejáveis pouco frequentes -(podem afetar até 1 em cada 100 pessoas)
-As análises ao sangue também poderão revelar:
-Efeitos indesejáveis raros -(podem afetar até 1 em cada 1000 pessoas)
-Se tiver algum destes sintomas, pare de imediato o seu medicamento e informe logo o seu médico.
-Se qualquer um dos efeitos indesejáveis se agravar informe o seu médico.
-Outros efeitos que podem ser observados durante o tratamento do VIH
-A frequência dos efeitos indesejáveis seguintes é desconhecida (a frequência não pode ser calculada a -partir dos dados disponíveis).
-Se observar qualquer um destes sintomas, informe o seu médico.
-Durante a terapêutica para o VIH pode haver um aumento do peso e dos níveis de lípidos e glucose no -sangue. Isto está em parte associado a uma recuperação da saúde e do estilo de vida e, no caso dos -lípidos no sangue, por vezes aos próprios medicamentos para o VIH. O seu médico irá realizar testes -para determinar estas alterações.
-Comunicação de efeitos indesejáveis
-Se tiver quaisquer efeitos indesejáveis, incluindo possíveis efeitos indesejáveis não indicados neste -folheto, fale com o seu médico ou farmacêutico. Também poderá comunicar efeitos indesejáveis -diretamente através do sistema nacional de notificação mencionado no Apêndice V. Ao comunicar -efeitos indesejáveis, estará a ajudar a fornecer mais informações sobre a segurança deste medicamento
Manter este medicamento fora da vista e do alcance das crianças.
-Não utilize este medicamento após o prazo de validade impresso na embalagem exterior e no frasco ou -fita blister, após {VAL}. O prazo de validade corresponde ao último dia do mês indicado.
-Conservar na embalagem de origem para proteger da humidade. Manter o frasco bem fechado. Não -utilizar se o selo por cima da abertura do frasco estiver partido ou ausente.
-Não deite fora quaisquer medicamentos na canalização ou no lixo doméstico. Pergunte ao seu -farmacêutico como deitar fora os medicamentos que já não utiliza. Estas medidas ajudarão a proteger -o ambiente.
Qual a composição de Biktarvy
-As substâncias ativas são o bictegravir, a emtricitabina e o tenofovir alafenamida. Cada comprimido -de Biktarvy contém bictegravir sódico equivalente a 30 mg de bictegravir, 120 mg de emtricitabina e -tenofovir alafenamida fumarato equivalente a 15 mg de tenofovir alafenamida.
-Os outros componentes são -Núcleo do comprimido -Celulose microcristalina (E460), croscarmelose sódica (E468), estearato de magnésio (E470b). -Película de revestimento -Álcool polivinílico (E203), dióxido de titânio (E171), macrogol (E1521), talco (E553b), óxido de ferro -vermelho (E172), óxido de ferro preto (E172).
-Qual o aspeto de Biktarvy e conteúdo da embalagem -Biktarvy 30 mg/120 mg/15 mg comprimidos revestidos por película são comprimidos revestidos por -película cor-de-rosa, em forma de cápsula, com “BVY” gravado num lado do comprimido e uma -ranhura no outro lado do comprimido.
-Os comprimidos são fornecidos num frasco. É possível que não sejam comercializadas todas as -apresentações.
-Biktarvy apresenta-se em embalagens contendo 1 frasco de 30 comprimidos e em embalagens com 3 -frascos, cada um dos quais contendo 30 comprimidos. Cada frasco contém um exsicante de sílica gel -que deve ser mantido dentro do frasco para ajudar a proteger os seus comprimidos. O exsicante de -sílica gel está contido numa saqueta ou recipiente separado e não deve ser engolido.
-Titular da Autorização de Introdução no Mercado
-Gilead Sciences Ireland UC -Carrigtohill -County Cork, T45 DP77 -Irlanda
-Fabricante
-Gilead Sciences Ireland UC -IDA Business & Technology Park -Carrigtohill -County Cork -Irlanda
Dovato 50 mg/300 mg film-coated tablets
-dolutegravir/lamivudine
-Read all of this leaflet carefully before you start taking this medicine because it contains important -information for you.
-Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) -infection: dolutegravir and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines called -integrase inhibitors (INIs), and lamivudine belongs to a group of anti-retroviral medicines called nucleoside -analogue reverse transcriptase inhibitors (NRTIs).
-Dovato is used to treat HIV in adults and adolescents over 12 years old who weigh at least 40 kg.
-Dovato does not cure HIV infection; it keeps the amount of virus in your body at a low level. This helps -maintain the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important -in helping your body to fight infection.
-Not everyone responds to treatment with Dovato in the same way. Your doctor will monitor the effectiveness -of your treatment.
Do not take Dovato
-Children
-This medicine is not for use in children under 12 years of age, because it has not been studied in these -patients.
-Other medicines and Dovato
-Tell your doctor if you are taking, have recently taken or might take any other medicines.
-Don't take Dovato with the following medicine:
-Some medicines can affect how Dovato works or make it more likely that you will have side effects. Dovato -can also affect how some other medicines work.
-Tell your doctor if you are taking any of the medicines in the following list:
-St. John’s wort (Hypericum perforatum), a herbal remedy to treat depression.
-Tell your doctor or pharmacist if you are taking any of these. Your doctor may decide to adjust -your dose or that you need extra check ups.
-Pregnancy
-If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
-Taking Dovato at the time of becoming pregnant or during the first six weeks of pregnancy, may increase the -risk of a birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
-If you could get pregnant while taking Dovato:
-Tell your doctor immediately if you become pregnant or are planning to become pregnant. Your doctor will -review your treatment. Do not stop taking Dovato without consulting your doctor, as this may harm you and -your unborn child.
-Breast-feeding
-Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to -the baby in breast milk. -A small amount of the ingredients in Dovato can also pass into your breast milk. -If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon -as possible.
-Driving and using machines
-Dovato can make you dizzy, and have other side effects that make you less alert.
-Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you -are not sure.
-Swallow the tablet with some liquid. Dovato can be taken with or without food.
-Use in adolescents
-Adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet -once a day.
-Antacid medicines
-Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less -effective. -Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it. -You can take other acid-lowering medicines like ranitidine and omeprazole at the same time as Dovato.
-Supplements or multivitamins containing calcium, iron or magnesium
-Supplements or multivitamins containing calcium, iron or magnesium can stop Dovato being absorbed into -your body and make it less effective. -If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron or -magnesium at the same time as Dovato. If you do not take Dovato with food, do not take a supplement or -multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at -least 2 hours after you take it.
-If you take more Dovato than you should
-If you take too many tablets of Dovato contact your doctor or pharmacist for advice. If possible, show -them the Dovato pack.
-If you forget to take Dovato
-If you miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the -dose you missed and take the next one at the usual time. Then continue your treatment as before.
-Don’t stop taking Dovato without advice from your doctor
-Take Dovato for as long as your doctor recommends. Don’t stop unless your doctor tells you to. Stopping -Dovato can affect your health and how future treatment works.
-If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very -important to talk to your doctor about any changes in your health.
-Allergic reactions
-Dovato contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity -reaction. This is an uncommon reaction (may affect up to 1 in 100 people) in people taking dolutegravir. If -you get any of the following symptoms:
-Very common side effects
-These may affect more than 1 in 10 people:
-Common side effects
-These may affect up to 1 in 10 people:
-Common side effects that may show up in blood tests are:
-Uncommon side effects
-These may affect up to 1 in 100 people:
-Uncommon side effects that may show up in blood tests are:
-Rare side effects
-These may affect up to 1 in 1000 people:
-Rare side effects that may show up in blood tests are:
-Very rare side effects -These may affect up to 1 in 10,000 people:
-Very rare side effects that may show up in blood tests are:
-Other possible side effects
-People taking combination therapy for HIV may get other side effects.
-Symptoms of infection and inflammation
-People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop -serious infections (opportunistic infections). Such infections may have been “silent” and not detected by the -weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms -usually include fever, plus some of the following:
-Joint pain, stiffness and bone problems
-Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this -condition, parts of the bone tissue are permanently damaged because of reduced blood supply to the bone. -People may be more likely to get this condition:
-Signs of osteonecrosis include:
-Weight, blood lipid and blood glucose effects:
-During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is -partly linked to restored health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor -will test for these changes.
-Reporting of side effects
-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed -in this leaflet. You can also report side effects directly via the national reporting system listed in -Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
-Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry -date refers to the last day of that month.
-This medicine does not require any special storage conditions.
-Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw -away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information -What Dovato contains
-What Dovato looks like and contents of the pack
-Dovato film-coated tablets are oval, biconvex, white tablets debossed with 'SV 137' on one face.
-The film-coated tablets are provided in bottles closed with child-resistant closures.
-Each bottle contains 30 film-coated tablets.
-Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available. -Not all pack sizes may be available in your c -ountry
Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
-What is in this leaflet
-Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.
-When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.
-Flucelvax Tetra is used to prevent flu in adults and children from 2 years of age.
-The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.
You should not receive Flucelvax Tetra:
-If you are allergic to:
-Warnings and precautions
-Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.
-BEFORE receiving the vaccine.
-As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.
-Other medicines and Flucelvax Tetra
-Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine. -Flucelvax Tetra may be given at the same time as other vaccines.
-Pregnancy and breast-feeding
-Pregnancy:
-Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccines may be given in any trimester of pregnancy.
-Breast-feeding:
-Use of Flucelvax Tetra during breast-feeding has not been studied. Flucelvax Tetra may be given during breast-feeding.
-Driving and using machines
-Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.
-Flucelvax Tetra contains sodium chloride and potassium chloride
-This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’. -This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free’
Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).
-Adults and children from 2 years of age:
-One dose of 0.5 ml
-If your child is younger than 9 years of age and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported during clinical trials and during general use:
-Very serious side effects
-Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:
-Serious side effects
-Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:
-Mild side effects
-Very common (may affect more than 1 in 10 people):
-Common (may affect up to 1 in 10 people):
-Not known (frequency cannot be estimated from the available data):
-Reporting of side effects
-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this vaccine out of the sight and reach of children. Store in a refrigerator (2 °C to 8 °C).
-Do not freeze.
-Keep the pre-filled syringe in the outer carton in order to protect from light.
-Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
-Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Flucelvax Tetra contains
-The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
-A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) 15 micrograms HA**
-A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) 15 micrograms HA**
-B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA**
-B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA**
-per 0.5 ml dose
-..............................................
-* propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in -which the influenza virus is grown);
-** haemagglutinin
-This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2022/2023 SEASON.
-The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
-What Flucelvax Tetra looks like and contents of the pack
-Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).
Flucelvax Tetra is a clear to slightly opalescent suspension.A single syringe contains 0.5 ml of suspension for injection.Flucelvax Tetra is available in packs containing 1 pre-filled syringe with or without needle or 10 pre- filled syringes with or without needles.
Not all pack sizes may be marketed.
Xenical 120mg hard capsules
Orlistat
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-What is in this leaflet:
-Xenical is a medicine used to treat obesity. It works in your digestive system to block about one-third of the fat in the food you eat from being digested. -Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal. The undigested fat cannot be absorbed and is eliminated by your body.
-Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.
Do not take XENICAL
-Warnings and precautions
-Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes). Be sure to discuss these and other medicines you may be taking with your doctor. Losing weight may mean you need adjustments to the dose of these medicines.
-To gain the maximum benefit from Xenical you should follow the nutrition program recommended to you by your doctor. As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
-This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces. The possibility of this happening may increase if Xenical is taken with a diet high in fat. In addition your daily intake of fat should be distributed evenly over three main meals because if Xenical is taken with a meal very high in fat, the possibility of gastrointestinal effects may increase.
-The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
-The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease. Inform your doctor whether you suffer from problems with your kidney.
-This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
-Children
-Xenical is not intended to be used in children.
-Other medicines and Xenical
-Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
-This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.
-Xenical may modify the activity of
-Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctor’s advice in taking a well balanced diet rich in fruit and vegetables. Your doctor may suggest you take a multivitamin supplement.
-Orlistat may unbalance an anticonvulsant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions. Please contact your doctor if you think that the frequency and/or severity of the convulsions have changed when taking Xenical together with antiepileptic drugs.
-Xenical is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
-Xenical with food and drink
-Xenical can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water.
-Pregnancy and breast-feeding -Taking Xenical during pregnancy is not recommended. -You must not breast-feed your infant during treatment with Xenical as it is not known whether Xenical passes into human milk.
-Driving and using machines -Xenical has no known effect on your ability to drive a car or operate machinery.
Always take Xenical exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day. It can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water.
-Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over three meals. This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time. To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks.
-Xenical only works in the presence of dietary fat. Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical need not be taken.
-Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.
-Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5 % of your body weight as measured at the start of treatment with Xenical.
-Xenical has been studied in long-term clinical studies of up to 4 years duration.
-If you take more XENICAL than you should
-If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.
-If you forget to take XENICAL
-If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times. Do not take a double dose. If you have missed several doses, please inform your doctor and follow the advice given to you. Do not change the prescribed dose yourself unless your doctor tells you to.
-If you have further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Xenical can cause side effects, although not everybody gets them.
-Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xenical.
-The majority of unwanted effects related to the use of Xenical result from its local action in your digestive system. These symptoms are generally mild, occur at the beginning of treatment and are particularly experienced after meals containing high levels of fat. Normally, these symptoms disappear if you continue treatment and keep to your recommended diet. -Very common side effects (affects more than 1 user in 10)
-Headache, abdominal pain/discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).
-Common side effects (affects 1 to 10 users in 100)
-Rectal pain/discomfort, soft stools, incontinence (stools), bloating (experienced by some people with -type 2 diabetes), tooth/gum disorder, irregularity of menstrual cycle, tiredness.
-The following side effects have also been reported but their frequency cannot be estimated from the available data:
-Allergic reactions. The main symptoms are itching, rash, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and feeling unwell. Skin blistering (including blisters that burst). Diverticulitis. Bleeding from the back passage (rectum). Increases in the levels of some liver enzymes may be found in blood tests. Hepatitis (inflammation of the liver). Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite. Stop Xenical if such symptoms occur and tell your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones). See Chapter 2, take special care with Xenical. Effects on clotting with anti-coagulants.
-Reporting of side effects
-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children
-Blister packs
-Do not use Xenical after the expiry date stated on the carton.
Do not store above 25 °C.
Store in original package and keep the blister in the outer carton in order to protect from light and moisture.
-Glass bottles
-Do not use Xenical after the expiry date stated on the bottle. Do not store above 30 °C.
Keep container tightly closed in order to protect from moisture.
-Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What XENICAL contains
-What XENICAL looks like and contents of the pack
-Xenical capsules are turquoise with the imprint “XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules. -Not all pack sizes may be marketed.
-Marketing Authorisation Holder -CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
-17489 Greifswald
-Germany
-Manufacturer -CHEPLAPHARM Arzneimittel GmbH Bahnhofstr. 1a
-17498 Mesekenhagen
-Germany
-or
-CHEPLAPHARM Arzneimittel GmbH Ziegelhof 23-24
-17489 Greifswald
-Germany
-This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
-Detailed information on this medicine is available on the European Medicines Agency web site: -http://www.ema.europa.eu